A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease
- Summary
- The main purpose of this study is to evaluate the efficacy and safety of retatrutide once weekly in participants with obesity and established cardiovascular disease (CVD). The study will last about 113 weeks.
- Acronym
- TRIUMPH-3
- Short title
- A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease
- Official title
- A Randomized, Double-Blind, Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly Compared to Placebo in Participants With Severe Obesity and Established Cardiovascular Disease
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2026-05-14
- First posted
- 2023-05-31
- Registry last updated
- 2026-07-30
- Primary completion date
- 2026-04-16
- Start date
- 2023-05-30
- Actual participants
- 1,946
- Participants
- 1,946
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Eli Lilly and Company
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05882045
- ClinicalTrials.gov ID
- NCT05882045
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Percent Change from Baseline in Body Weight
Timeframe: Baseline, Week 80
Change from Baseline in Body Mass Index (BMI)
Timeframe: Baseline, Week 80
Change from Baseline in Waist Circumference
Timeframe: Baseline, Week 80
Percent Change from Baseline in Total Cholesterol
Timeframe: Baseline, Week 80
Percent Change from Baseline in Triglycerides
Timeframe: Baseline, Week 80
Change from Baseline in Systolic Blood Pressure (SBP)
Timeframe: Baseline, Week 80
Change from Baseline in Diastolic Blood Pressure (DBP)
Timeframe: Baseline, Week 80
Change from Baseline in Hemoglobin A1c (HbA1c)
Timeframe: Baseline, Week 80
Percent Change from Baseline in Fasting Insulin
Timeframe: Baseline, Week 80
Change from Baseline in Short Form version 2 (SF-36v2) Acute Form Physical Function Domain Score
Timeframe: Baseline, Week 80
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Cure (AUC)
Timeframe: Baseline to Week 80
AUC is presented as a single average measure of AUC across the study duration.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
-
Have a body mass index (BMI) ≥35.0 kilogram/square meter (kg/m²).
-
Have established cardiovascular (CV) disease with at least 1 of the following:
- prior myocardial infarction
- prior ischemic or hemorrhagic stroke, or
- symptomatic peripheral arterial disease
-
Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight.
- Have had acute myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure within 90 days prior to screening.
- Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
- Have a prior or planned surgical treatment of obesity.
- Have a change in body weight greater than 5 kg (11 pounds) within 90 days prior to screening.
- Have Type 1 diabetes.
- Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- Have had pancreatitis.
- Central Phoenix Medical ClinicPhoenix, United States
- Valley Clinical Trials, Inc.Covina, United States
- Neuro-Pain Medical CenterFresno, United States
- Valley ResearchFresno, United States
- Collaborative Neuroscience Research, LLCLos Alamitos, United States
- Velocity Clinical Research, WestlakeLos Angeles, United States
- Valley Clinical Trials, Inc.Northridge, United States
- Velocity Clinical Research, Panorama CityVan Nuys, United States
- Chase Medical Research, LLCWaterbury, United States
- Indago Research & Health Center, IncHialeah, United States
- Clinical Neuroscience Solutions, Inc. dba CNS HealthcareJacksonville, United States
- Clinical Neuroscience Solutions, Inc.Orlando, United States
- Charter Research - Winter ParkOrlando, United States
- Progressive Medical ResearchPort Orange, United States
- Pacific Diabetes & Endocrine CenterHonolulu, United States
- Elite Clinical TrialsBlackfoot, United States
- Humphreys Diabetes CenterBoise, United States
- Northwestern UniversityChicago, United States
- Great Lakes Clinical Trials - GurneeGurnee, United States
- Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research CooperativeSpringfield, United States
- Brengle Family MedicineIndianapolis, United States
- Iowa Diabetes and Endocrinology Research CenterWest Des Moines, United States
- Cotton O'Neil Diabetes & EndocrinologyTopeka, United States
- MedVadis Research CorporationWaltham, United States
- StudyMetrix ResearchCity of Saint Peters, United States
And 144 more, listed on the interactive page.
- Related resource (trials.lilly.com)
- 2023
- 2023-503659-88-00
- J1I-MC-GZBM
Related records
Drugs (1)
Lead sponsors (1)
Conditions (2)
- Cardiovascular disorder
- Obesity disorder Primary condition